NL-OMON30695尚未招募不适用
Towards a further extension of the potential donor pool for highly sensitized patients. - Extension of the potential donor pool for highly sensitized patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Older than 18 years.
- •Patients with renal failure on the Eurotransplant kidney waiting list.
- •PRA in historical sera higher than 85%.
- •More than 1 year on the AM list.
- •A signed informed consent form.
排除标准
- •1) Patients with severe gastrointestinal disorders, that interfere with their ability to receive or absorb oral medication and patients with severe diarrhea.
- •2) Patients with active peptic ulcer disease.
- •3) Patients or their donors with serologic evidence of HIV, HCV or HBsAg in the past.
- •4) Patients with malignancies (current or history within last 5 years) except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
- •5) Patients with systemic infection requiring therapy at the time of entry in the study.
- •6) Patients with any form of substance abuse or psychiatric disorder which in the opinion of the investigator might invalidate patients communication with the clinician.
研究者
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